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Clinical Trial of Teriparatide in Japan

Information source: Eli Lilly and Company
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Osteoporosis

Intervention: Teriparatide (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Eli Lilly and Company

Official(s) and/or principal investigator(s):
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study Director, Affiliation: Eli Lilly and Company

Summary

The purpose of this study is to assess the Efficacy and Safety of Teriparatide in Japanese Postmenopausal Women with Osteoporosis.

Clinical Details

Official title: Assessment of Dose Response of LY333334 in Japanese Postmenopausal Women With Osteoporosis

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome: To assess the dose response of LY333334 with the percent change from baseline in lumbar spine mineral density at endpoint

Secondary outcome: To evaluate the safety of LY333334

Eligibility

Minimum age: 55 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Japanese women with primary osteoporosis

- Postmenopausal women aged at least 55 years

- Patients with a high risk for fracture

Exclusion Criteria:

- History of metabolic bone disorders other than osteoporosis

- History of any secondary causes of osteoporosis

- History of malignant neoplasm within the last 5 years except for superficial basal

cell carcinoma or squamous cell carcinoma of the skin that has been definitively treated

- Severe or chronically disabling conditions other than osteoporosis

Locations and Contacts

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician, Hiroshima, Japan

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician, Hyogo, Japan

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician, Kagoshima, Japan

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician, Nagano, Japan

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician, Osaka, Japan

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician, Tokyo, Japan

Additional Information

Lilly Clinical Trial Registry

Starting date: February 2005
Last updated: November 5, 2007

Page last updated: August 20, 2015

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